MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Polaris? Loop; stent, ureteral

Model Number	M0061552230
Medical Device Problem Codes	Calcified (1077); Nonstandard Device (1420); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a040501 captures the reportable investigation result of stent calcified.
Event or Problem Description
It was reported that a polaris loop ureteral stent was used in a ureteral lithotripsy and stone removal in the ureter.During the procedure, when the stent was inserted, it could not cross the stenosis of the ureter.The procedure was completed with another of the same device and there were no patient complications reported.Analysis of the returned device identified that the stent was calcified.

• Brand Name: Polaris? Loop
• Common Device Name: stent, ureteral
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22611928
• Report Number: 2124215-2025-49602
• Device Sequence Number: 18532874
• Product Code: FAD
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061552230
• Device Catalogue Number: M0061552230
• Device Lot Number: 0033130066
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 149 LB